Events

Device Recall St. Jude Medical CPS Aim 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St Jude Medical CRMD 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    35616
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1167-06
  • 사례 시작날짜
    2006-06-01
  • 사례 출판 날짜
    2006-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46477
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, Percutaneous - Product Code DQY
  • 원인
    Sterility-some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
  • 조치
    The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.

Device

Device Recall St. Jude Medical CPS Aim
  • 모델명 / 제조번호(시리얼번호)
    All lots with a manufacturing date of May 30, 2006 or earlier
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • 제품 설명
    CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • 제조사 주소
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA